Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT01293058
Status:
COMPLETED
Last Update Posted:
2011-02-10
First Post:
2011-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062787', 'term': 'Drug Overdose'}], 'ancestors': [{'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-09', 'studyFirstSubmitDate': '2011-02-09', 'studyFirstSubmitQcDate': '2011-02-09', 'lastUpdatePostDateStruct': {'date': '2011-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of consciousness', 'timeFrame': '4 min after naloxone administration', 'description': 'The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration'}], 'secondaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': 'at 4 min after naloxone administration', 'description': 'The investigators evaluated blood pressure 4 minutes after naloxone administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['opioid', 'overdose', 'naloxone', 'intranasal'], 'conditions': ['Morphinan Opioid Overdose']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://mui.ac.ir', 'label': 'Isfahan university of medical sciences'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine which route of administration is better for treatment of opioid overdosed patients', 'detailedDescription': 'In intravenous drug abusers (IDUs), as a result of previous intravenous substance abuse, the predictable difficult cannulate exist and cause the delay administration of antidote therapy. Additionally, IDUs are also at increased risk of carrying blood borne infections that could be transmitted to healthcare workers through needle stick injuries. The investigators aimed to compare intranasal administration of naloxone with intravenous route.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with the range of 15-50 years old\n\n * Who were suspicious to opioid overdoses based on history and having clinical appearance such as miotic pupils with loss of consciousness\n * Give response to naloxone with increasing the level of consciousness\n\nExclusion Criteria:\n\n* Not giving response to naloxone and suspicious to have another reason for loss of consciousness'}, 'identificationModule': {'nctId': 'NCT01293058', 'briefTitle': 'Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Study of Routs of Naloxone Administration for Opioid Overdosed Patients', 'orgStudyIdInfo': {'id': 'ASD-1213-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intravenous', 'description': 'The investigators administered intravenous naloxone for our opioid overdose patients', 'interventionNames': ['Drug: Intravenous']}, {'type': 'OTHER', 'label': 'Intranasal', 'description': 'The investigators administered intranasal naloxone for treatment of our patients', 'interventionNames': ['Drug: Intranasal naloxone']}], 'interventions': [{'name': 'Intranasal naloxone', 'type': 'DRUG', 'description': 'spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness', 'armGroupLabels': ['Intranasal']}, {'name': 'Intravenous', 'type': 'DRUG', 'description': 'Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness', 'armGroupLabels': ['Intravenous']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'state': 'Isfahan', 'country': 'Iran', 'facility': 'Noor university hospital', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'overallOfficials': [{'name': 'Nastaran Izadi, A.Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isfahan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Alireza Yousefy, Associate Professor of Medical Education', 'oldOrganization': 'Isfahan University of Medical Sciences'}}}}